{"entity":{"id":"alemtuzumab","kind":"drug","name":"Alemtuzumab","aka":["MabCampath","Lemtrada (multiple sclerosis formulation)"],"tldr":"Alemtuzumab (Campath) is an antibody that wipes out lymphocytes carrying the CD52 marker. It is approved for chronic lymphocytic leukaemia and is supplied in the US through a restricted distribution programme.","summary":"Alemtuzumab is a CD52-directed cytolytic antibody approved by the FDA in 2001 (accelerated) for fludarabine-refractory B-cell CLL, with full approval as a single agent for B-CLL after the CAM307 randomised trial against chlorambucil in previously untreated patients (297 randomised; longer progression-free survival on alemtuzumab). Profound lymphopenia brings cytomegalovirus reactivation and opportunistic infection, so prophylaxis and monitoring are mandatory. In the EU, MabCampath was authorised in 2001 and withdrawn in 2012 when the sponsor repositioned the molecule as Lemtrada for multiple sclerosis; Campath remains available for CLL through the US Campath Distribution Program. It is also used off label as lymphodepleting conditioning in stem cell transplantation.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Alemtuzumab","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=alemtuzumab"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/alemtuzumab"}],"tags":["nci-list"],"related":[],"cancers":["cll","peripheral-t-cell-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["cd52"],"drugs":[],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05607420"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Lymphoma biology: CD52 is a 12-amino-acid glycopeptide on a lipid anchor, present at very high surface density, which makes it an efficient complement-fixing target; it is also on normal B cells, T cells, monocytes and dendritic cells, which is why this antibody causes the deepest and longest lymphopenia of any used in lymphoma, with CD4 counts that can stay low for a year and with cytomegalovirus, Pneumocystis and fungal infection to match. Loss of the lipid anchor removes the antigen without touching the gene, which is the described escape route."],"brand":"Campath","modality":"Monoclonal antibody (anti-CD52)","mechanism":"Humanised IgG1 that binds CD52 on B and T lymphocytes, monocytes and NK cells; kills by antibody-dependent cellular cytotoxicity and complement-dependent lysis.","approvals":[{"region":"US","year":2001,"indication":"B-cell chronic lymphocytic leukaemia (single agent)"},{"region":"EU","year":2001,"indication":"B-CLL after fludarabine (MabCampath; authorisation withdrawn 2012)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2001-05-07","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"B-cell CLL treated with alkylating agents and failed fludarabine therapy"},{"date":"2007-09-19","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2001 converted to traditional approval 6.4 years after it was granted.","indication":"B-cell CLL treated with alkylating agents and failed fludarabine therapy"}]},"route":"/drugs/alemtuzumab/","neighbours":{"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"},{"id":"sezary-syndrome","kind":"cancer","name":"Sezary syndrome","route":"/cancers/sezary-syndrome/"},{"id":"t-large-granular-lymphocytic-leukaemia","kind":"cancer","name":"T-cell large granular lymphocytic leukaemia","route":"/cancers/t-large-granular-lymphocytic-leukaemia/"},{"id":"t-cell-prolymphocytic-leukaemia","kind":"cancer","name":"T-cell prolymphocytic leukaemia","route":"/cancers/t-cell-prolymphocytic-leukaemia/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"cd52","kind":"target","name":"CD52","route":"/targets/cd52/"}],"company":[{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}],"trial":[{"id":"nct05607420","kind":"trial","name":"Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma","route":"/trials/nct05607420/"}],"term":[{"id":"lymphoma-tx-pjp-and-infection-prophylaxis","kind":"term","name":"Infection prophylaxis in lymphoma: PJP, herpes, fungal risk and vaccination","route":"/terms/lymphoma-tx-pjp-and-infection-prophylaxis/"}]}}